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目的评价和比较特拉唑嗪、非那司提和坦素罗辛,以及其中任意两药联用与单药治疗良性前列腺增生症(benign prostatic hyperplasia,BPH)的有效性。方法计算机检索MEDLINE(1966~2004.12)、EMBASE(1984~2004.12)、Cochrane图书馆(2004年第4期)、美国《生物学文摘》光盘数据库(1990~2004.12)和中国生物医学文献光盘数据库(1978~2004.12)等,手检10种相关杂志。纳入与有效性有关的随机对照试验(RCT)和半随机对照试验(CCT),并追索已纳入文献的参考文献。由至少两位系统评价员独立进行文献筛查、质量评价和资料提取,并交叉核对,不同意见请第三者裁决。采用RevMan4.2软件进行Meta分析。结果共初检出656篇文献,经筛选后最后纳入12篇原始研究(2471例)进行分析,包括11篇RCT,1篇CCT。Meta分析结果显示:与特拉唑嗪比较,坦素罗辛改善国际前列腺症状评分(international prostatic symptom score,IPSS)更明显[WMD=0.75,95%CI(0.03,1.46),P=0.04],差异有统计学意义,但在平均尿流率(average rate of urine flow,AFR)改善程度[WMD=0.23,95%CI(-0.39,0.85),P=0.46]、残余尿量改善程度[WMD=0.82,95%CI(-2.92,4.57),P=0.67]以及减小前列腺体积的效果[WMD=2.20,95%CI(-3.99,8.39),P=0.49]方面,两者差异均无统计学意义。非那司提与坦素罗辛比较,两者在改善IPSS[WMD=0.65,95%CI(-0.45,1.75),P=0.25]和最大尿流率方面[WMD=0.39,95%CI(-0.72,1.51),P=0.49],其差异均无统计学意义。仅有两个研究比较了非那司提与特拉唑嗪对最大尿流率的影响,且结论各异。仅有1个研究(538例)比较了单用非那司提、特拉唑嗪与联用非那司提和特拉唑嗪治疗良性前列腺增生症的有效率,结果显示两药联用的有效率明显优于单用非那司提,但与单用特拉唑嗪无明显差异。结论非那司提、特拉唑嗪和坦素罗辛治疗良性前列腺增生症的效果差别不大。在改善IPSS和生活质量方面,坦素罗辛似乎优于特拉唑嗪;非那司提与特拉唑嗪联用比单用非那司提有效率高,但不比单用特拉唑嗪效果好。结合安全性和经济性考虑,推荐临床短期单用坦素罗辛治疗良性前列腺增生症。长期治疗方案目前尚无足够的证据支持,有待进一步研究;在新证据产生之前不推荐联合用药。鉴于有关临床研究现状,呼吁提高国内外原始研究质量,增大样本量,开展高质量临床研究。
Objectives To evaluate and compare the effectiveness of terazosin, finasteride and tamsulosin, and any two of them in combination with monotherapy in the treatment of benign prostatic hyperplasia (BPH). Methods The data from MEDLINE (1966 ~ 2004.12), EMBASE (1984 ~ 2004.12), The Cochrane Library (2004), American Abstracts CD (1990 ~ 2004.12) and China Biomedical Literature Disc Database ~ 2004.12), hand check 10 kinds of related magazines. Randomly controlled trials (RCTs) and semi-randomized controlled trials (CCTs) related to efficacy were included and references included in the literature were sought. At least two system reviewers independently conduct literature screening, quality evaluation and data extraction, and cross-check, disagree with the decision of the third party. RevMan4.2 software for Meta analysis. Results A total of 656 articles were initially detected. After screening, 12 original articles (2471 cases) were finally included in the analysis, including 11 RCTs and 1 CCT. Meta-analysis showed that compared with terazosin, tamsulosin showed more significant improvement in the international prostatic symptom score (WMD = 0.75, 95% CI 0.03, 1.46, P = 0.04) The difference was statistically significant, but the improvement of average rate of urine flow (AFR) [WMD = 0.23, 95% CI (-0.39, 0.85), P = 0.46] = 0.82, 95% CI (-2.92, 4.57), P = 0.67], and the effect of reducing prostate volume [WMD = 2.20,95% CI (-3.99,8.39), P = 0.49] Statistical significance. Both finasteride and tamsulosin showed significant improvement in IPSS [WMD = 0.65, 95% CI (-0.45, 1.75), P = 0.25] and maximal uroflow rate [WMD = 0.39, 95% CI -0.72, 1.51), P = 0.49], the difference was not statistically significant. Only two studies compared the effects of finasteride and terazosin on the maximal uroflow rate, with various conclusions. Only one study (538 patients) compared the efficacy of finasteride, terazosin, fexalone and terazosin in the treatment of benign prostatic hyperplasia. The results showed that the combination of the two drugs Efficiency was significantly superior to finasteride alone, but with terazosin alone no significant difference. Conclusion Finasteride, terazosin and tamsulosin treatment of benign prostatic hyperplasia effect is not very different. Tamsulosin appears to be superior to terazosin in terms of improving IPSS and quality of life; finasteride is more effective than terazosin in combination with prazosin alone but not more effective than terazosin alone Good effect. Combination of safety and economic considerations, the recommended clinical short-term single use of tamsulosin in the treatment of benign prostatic hyperplasia. Long-term treatment programs currently do not have enough evidence to support further research; combination therapy is not recommended until new evidence is available. In view of the current status of clinical research, we call for the improvement of the quality of original research at home and abroad, increase the sample size, and conduct high-quality clinical research.